Rehab in Mild DCM: Study Protocol for a Feasibility Randomised Controlled Trial to Compare the Effectiveness of a Structured Rehabilitation Intervention to Clinical Surveillance in People With Mild Stable Degenerative Cervical Myelopathy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acceptability of the intervention to the participants and clinicians
研究概览
简要总结
The goal of this feasibility RCT is to establish the feasibility of undertaking a RCT investigating the effectiveness of a multi component structured rehabilitation intervention aiming at reducing physical disability in people with mild stable Degenerative Cervical Myelopathy. The main question it will answer are what is the incidence of mild stable DCM in the neurosurgical OPD clinics, what is the eligibility rate and participate rate of those eligible. It will also investigate the acceptability of the intervention to both participants and clinicians and participant retention.
Researchers will compare a structured rehabilitation intervention to clinical surveillance. The structured rehabilitation intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Every participant will have a unique identifier. The outcome assessors will be blinded to group allocation. Clinicians delivering the interventions and trial participants will not be blinded to group allocations due to the nature of the intervention (56). Participants will be asked in advance of attending for their 12 week follow up not to disclose their group allocation with the outcome assessor. Data analysts will be blinded to group allocation. Unblinding will only occur in exceptional circumstances when knowledge of the group allocation is essential for further management of the participant (57).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diagnosis of DCM (Clinical symptom of DCM +/- Upper motor neuron sign + imaging evidence of cervical cord compression). Diagnosis will be confirmed by a consultant neurosurgeon (19).
- •Modified Japanese Orthopaedic assessment (mJOA) score of 15-17, indicating mild DCM. The mJOA is a clinician administered validated measure of DCM severity (20)
- •Adequate comprehension of English to understand the purpose of the study and give written informed consent
排除标准
- •Patient or surgeon preference for urgent surgical decompression for progressive DCM, motor radiculopathy or severe unrelenting radicular arm pain or significant risk factors for progression including co-existing cervical radiculopathy and circumferential cord compression.
- •Diagnosis of other neurological condition that could confound assessment.
- •Involvement in another clinical study or trial
- •Pregnancy
- •If the participant is unable to commit to a 12-week programme of up to 10 sessions of supervised rehabilitation and participating in a regular home exercise programme for the duration of the study.
研究组 & 干预措施
Structured rehabilitation intervention
The SRI will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.
干预措施: Structured rehabilitation intervention (Other)
Clinical surveillance
Participants assigned to the clinical surveillance control group will be invited to attend a single, one to one education session which will be supplemented with a written patient information booklet after which they will be scheduled for a 12 week follow up.
干预措施: Clinical Surveillance (Other)
结局指标
主要结局
Acceptability of the intervention to the participants and clinicians
时间窗: 12 weeks
Semi-structured interviews
Incidence of mild stable DCM
时间窗: Baseline
Number of people with mild stable DCM during the study period/ number of NP seen.
Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria
时间窗: Baseline
The number of people with mild stable DCM over the study period- the number of people with mild stable DCM who are eligible to participate in the study.
Participant recruitment rate
时间窗: Baseline
The number of participants recruited per month
Participant adherence to the intervention
时间窗: 12 weeks
The number of scheduled sessions attended by the participants.
Clinician adherence to the intervention
时间窗: 12 weeks
The number of core intervention components included in each treatment session
Burden of measurement tool completion
时间窗: 12 weeks
Semi structured interview
Participant retention rate
时间窗: 12 weeks
Loss to follow up rate and reasons for loss to follow up
次要结局
- Physical component score of the short form (SF) 36(Baseline and 12 weeks)
- Modified Japanese Orthopaedic association index (mJOA)(Baseline and 12 weeks)
- Neck disability index(Baseline and 12 weeks)
- Spinal adverse events severity scale(12 weeks)